In Group A the anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery

Device: Laser-assisted cataract surgery

The anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery

Active Comparator: Group B

Group B acts as a control group where the capsulotomy as well as the lens fragmentation is performed manually.

Device: Manually performed cataract surgery

The anterior capsulotomy and lens fragmentation will be performed manually.

Detailed Description:

A detailed pre-operative examination will ensure that every interested and willing patient fulfills the inclusion criteria of this study. For the proposed contralateral eye study between 30 and 35 patients will be enrolled whereas one eye will randomized undergo a manual cataract surgery and the other one a laser assisted cataract surgery. In total between 60 and 70 eyes will be included in the study. Pre-operative examinations are included to confirm to the clinical practice. Examinations on the day of surgery and any occurrence during the procedure are also listed. Post-operative examinations, which should document any occurrence, the outcome of and possible differences between the treatment techniques, are to be carried out after 1 day, 1 week, 1 month, 3 months and 6 months. After 6 month a final report including the study results will be produced.

The study is carried out in compliance with MEDDEV 2.7.1 Evaluation of Clinical Data: A Guide for Manufacturers and Notified Bodies, ICH E6 (R1) Good Clinical Practice (GCP), Declaration of Helsinki as well as the applicable local regulations such as notification requirements and current order of profession of the primary investigators.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Clear corneal media

Patients must be at least 18 years of age

Patients must have read, understood and signed the Patient Information

Patients are willing and able to return for follow-up examinations

Topographic Astigmatism ≤ 1.5 dpt

Patient will get a monofocal IOL (Envista) implanted

Exclusion Criteria:

On a keratometric map of the cornea, the minimal and maximal K-values of the central 3mm zone must not differ by more than 5D (exclusion criterium for Group A only)

The maximum K- value may not exceed 60D, the minimal value may not be smaller than 37D (exclusion criterium for Group A only)

Corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light (exclusion criteria for Group A only)

Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally

Abnormal examination results from Orbscan (exclusion criteria for Group A only; , age related changes are acceptable

Patients who are pregnant or nursing

Patients who do not give informed consent

Patients with concentration disorders, epilepsy and other complicating diseases

Patients regularly taking medicines that could influence the result of the treatment

Patients who are participating in another ophthalmological clinical study

Patients with an anterior chamber depth (ACD) < 1.5 mm or ACD > 4.8 mm as measured as from the corneal endothelium.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01769313